Cerdak Basic
K-Number: K153138 · 2017-06-23
Decision Date2017-06-23
Product CodeFRO
DecisionSubstantially Equivalent
Device Summary
Cerdak Basic is a medical device manufactured by Bu Polysciences Equipment & Trading, LLC. It received FDA 510(k) clearance on 2017-06-23 under approval number K153138. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Cerdak Basic?
Cerdak Basic is a medical device that received FDA 510(k) clearance on 2017-06-23. It is manufactured by Bu Polysciences Equipment & Trading, LLC. The 510(k) number is K153138.
When was Cerdak Basic approved by the FDA?
Cerdak Basic received FDA 510(k) clearance on 2017-06-23, under approval number K153138.
What company makes Cerdak Basic?
Cerdak Basic is manufactured by Bu Polysciences Equipment & Trading, LLC.
What is the FDA product code for Cerdak Basic?
The FDA product code for Cerdak Basic is FRO. This falls under the Anesthesiology category.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.